Halyard 94906Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10680651949063), received between Jun 5, 2019 and Jun 5, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2019Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT "THE TUBE WAS LEAKING AND WAS DUE TO BE CHANGED IN TWO DAYS. THE NURSE DECIDED TO REPLACE THE TUBE. WHEN SHE ATTEMPTED TO ASPIRATE THE FLUID FROM THE BALLOON THE TUBE BROKE LEAVING THE END IN THE STOMA. THE UNIT STAFF COULD VISUALIZE THE BROKEN OFF PIECE BUT WERE UNABLE TO RETRIEVE IT...[THE PATIENT] HAD AN UPPER GI [GASTROINTESTINAL] ENDOSCOPY PERFORMED WHERE THERE WAS NO ENDOSCOPIC EVIDENCE OF FOREIGN BODY." ADDITIONAL INFORMATION RECEIVED ON 21-MAY-2019 INDICATED THAT THE PATIENT PASSED THE REMAINDER OF THE TUBE WITHOUT INCIDENT. SEQUELA TO ENDOSCOPY, THE PATIENT MAY HAVE ASPIRATED AND HAS DEVELOPED PNEUMONIA REQUIRING SUPPLEMENTAL OXYGEN.

  Patient problems: Pneumonia

  MAUDE report 8669909 ↗